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Completed

NCT Number: NCT04866563

A Study of Efficacy and Safety of AX-8 in Chronic Cough

This is a randomized, double-blind, placebo-controlled, crossover, multicenter study of AX-8 in participants with unexplained or refractory chronic cough designed to evaluate the effectiveness of AX-8 in reducing cough frequency.

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Key information

Conditions

Chronic Cough Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Axalbion Study Site 4406, Birmingham, England, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chest radiograph or computed tomography (CT) of the thorax approximately 12 months before screening not demonstrating any abnormality considered to be significantly contributing to the chronic cough
  • Have a diagnosis of refractory chronic cough (RCC) or unexplained chronic cough (UCC) for at least one year
  • Women of childbearing potential and their male partners must use 2 acceptable methods of contraception
  • Male subjects and their female partners of childbearing potential must use 2 acceptable methods of contraception
  • Have provided written informed consent

Exclusion criteria

  • Positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
  • Current smoker (including e-cigarettes), individuals who have given up smoking within the past 12 months, or individuals with a smoking history of 20 pack-years
  • Treatment with an ACE-inhibitor as the potential cause of a subject's cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit
  • History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks
  • History of cystic fibrosis
  • Positive test for any drug of abuse
  • History of malignancy within 5 years prior to the Baseline Visit
  • History of infection or known active infection with human immunodeficiency (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • History of hypersensitivity or intolerance to AX-8 or other TRPM8 agonists or any of the excipients

Treatment and study plan

AX-8, Part 1 of the study

Drug

orally disintegrating tablets, BID

Placebo, Part 1 of the study

Drug

orally disintegrating tablets, BID

AX-8, Part 2 of the study

Drug

orally disintegrating tablets, TID

Placebo, Part 2 of the study

Drug

orally disintegrating tablets, TID

Primary outcomes

  1. Part 1 of the study: Change from Baseline in objective cough frequency in the 8 hours after the first dose of the day (i.e., Dose 1) on the 1st day of treatment of each study period

    Time frame: Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period

    Assessment of number of coughs per hour to be evaluated using a digital recording device

  2. Part 2 of the study: Change from Baseline in objective cough frequency in the 4 hours after the first dose of the day (i.e., Dose 1) on the 1st day of treatment of each study period

    Time frame: Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period

    Assessment of number of coughs per hour to be evaluated using a digital recording device

Secondary outcomes

  1. Change from Baseline in awake cough frequency

    Time frame: Baseline (i.e., Days -1 and 22), the 1st day of treatment (i.e., Days 1 and 23) and the 14th day of treatment (i.e., Days 14 and 36) of each study period

    Assessment of awake coughs per hour (average hourly cough frequency while the participant is awake based on sound recordings), to be evaluated using a digital recording device

  2. Change from Baseline in Cough Severity Visual Analog Scale (VAS) score

    Time frame: Baseline (i.e., Days -1 and 22), the 1st day of treatment (i.e., Days 1 and 23) and the 14th day of treatment (i.e., Days 14 and 36) of each study period

    Cough Severity is determined through the use of a 100 mm visual analogue scale (VAS) (ranging between 0 for "no cough" and 100 for "worst cough").

  3. Incidence (percent of participants) of treatment-emergent adverse events (TEAEs)

    Time frame: From first dose of study drug (i.e., Dose 1 on Day 1) to follow-up visit (i.e., Day 50, included)

    TEAEs are defined as those AEs (i.e., a new event or an exacerbation of a pre-existing condition) occurring on or after the first study dosing (i.e., Dose 1 on Day 1).

  4. Incidence (percent of participants) of serious adverse events (SAEs)

    Time frame: From screening visit (i.e., Days -21 to -2) to follow-up visit (i.e., Day 50, included)

    An SAE is an adverse events occurring during any study phase and that fulfils one or more of the following: results in death, is life-threatening, requires patient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a significant or important medical event, or is a congenital anomaly/birth defect in the offspring of a subject who received study drug.

Sponsors and collaborators

Lead sponsor

Axalbion SA

Industry

Registry information

Official study title

A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients With Chronic Cough

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2021
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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